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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

India’s Move Toward Price Caps on Medical Devices Gathers Pace

India’s Department of Pharmaceuticals (DoP) is forming a committee to assess which medical devices to bring under price control. The action marks a significant step in the long-running and increasingly well-received campaign to control the prices of certain medical devices.

Maharashtra Food and Drug Administration (FDA) raised the issue with the National Pharmaceutical Pricing Authority (NPPA) in 2013 but the topic has only gained traction over the past six months. The Economic Times and PharmaBiz covered the latest developments this week, reporting a committee is working on a list of devices to price cap that is likely to include stents and catheters, the cost of which has become a controversial and political topic in recent months.

The committee will evaluate the importance, performance and global regulatory standing of each device before making its decision. In parallel, the committee will debate how to set the prices of the affected devices. The goal is to come up with a formula for setting medical device prices. At least some members of the medical device manufacturing industry are in favor of the plan.

China Posts Plan to Strengthen Patent Law

China has released draft changes to its patent law for consultation. The amendments are intended to strengthen the rights of patent holders and increase the penalties for anyone found to have maliciously infringed their rights, China Daily reports.

Officials released the draft on April 1, more than two years after an early version was sent to the State Council for approval. Early feedback appears to be positive, with representatives of the All-China Patent Attorney Association, telecommunications firm Huawei and Tongji University’s law department coming out in favor of aspects of the law.

Proposals in the draft include giving courts the power to force suspects to turn over their financial records and hand out tougher penalties. The text would also make Internet service providers take actions to stop the sale of counterfeits online, an important topic for China as it moves toward allowing websites to sell prescription medicines.

Maharashtra FDA Slashes Approval Times, Backlog Using Online System

Maharashtra FDA has cut the time it takes to process manufacturing licensing applications and slashed its backlog by adopting an online system, The Asian Age reports. Over the six months the regulator has used the system, it claims to have cleared 15,000 applications.

As it stands, Maharashtra FDA has only implemented the online Extended Licensing Node (XLN) in the Konkan district, but is set to roll out the technology across the state over the next two months. The decision to expand is underpinned by data from Konkan, where the regulator claims to be processing applications in 15 days. Prior to adopting XLN, the timeframe was two months.

“Various functions that earlier required manpower will now be fulfilled through XLN software...[and] the functioning of FDA will also be more centralized and paperless,” Sanjay Patil, joint commissioner of Maharashtra FDA, said. The Drug Controller General of India (DCGI) is also planning to take licensing applications online, a switch he hopes to make in the next two years.

China Moves to Limit Role of Intermediaries in Drug Approvals

The Chinese government has moved the curb the use of intermediary service providers in the approval process for drugs and other products. Such intermediaries reportedly often have ties to the government and are viewed by leading Chinese officials as a possible cause of corruption.

China’s cabinet shared a notice late last week warning that it will not tolerate the preferential licensing of intermediaries with links to the government, Xinhua reports. Intermediaries must also clearly tell clients what administrative processes they face and not introduce unnecessary reviews.

In a separate development, CFDA officials are to take a crash course in how their peers in the United States regulate drugs and medical devices. The plan is for senior FDA officials to hold a series of lectures for CFDA.

Other News:

Indian regulators have banned the sale of the five-in-one Pentavac vaccine and sent 51 samples for testing after a two-month-old infant died within 48 hours of receiving a shot. Similar vaccines have caused controversies in multiple countries, but a previous investigation by the World Health Organization recommended continuing their use. The Tribune, More

Australia’s Therapeutic Goods Administration (TGA) has updated its guidelines on lowering the assessment fees for medical devices. TGA has made small revisions to the text that was first introduced and updated in 2011, such as the addition of document numbering and a switch from fractions to percentages. TGA Guidelines

Life Science Leader has taken a look at Japan’s regenerative medicine laws and what they mean for companies in the sector. The laws open the door to seven-year conditional approvals on the basis of data from small, single-arm clinical trials. At the end of the conditional approval window, firms can apply for a full license on the basis of data generated over the preceding years. LSL

Singapore’s Health Sciences Authority (HSA) has warned the public about five illegal sexual enhancement products being sold online. Tests by HSA found three of the products contained sildenafil — the active ingredient in Viagra — while nortadalafil and the anesthetic lignocaine were present in the other two brands. HGA Notice

Express Pharma has reported on the implications of India’s controversial decision to ban the use of PET packaging for certain products. Responses to the decision and predictions of its effects vary significantly, with worst-case scenario forecasters saying thousands of small companies will shut down, leaving 100 times as many people unemployed. Express Pharma

The Indian commerce ministry is talking to businesses about the merits of joining the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). Signing up could make it easier for Indian manufacturers to access international markets but also increase the cost of complying with standards. The Economic Times